MQB · Class II · 21 CFR 892.1680

FDA Product Code MQB: Solid State X-ray Imager (flat Panel/digital Imager)

FDA product code MQB covers solid-state X-ray imagers, also known as flat panel detectors or digital image receptors.

These devices replace traditional film and computed radiography cassettes with direct digital capture of X-ray images. They provide higher image quality, lower radiation dose, and immediate image availability compared to conventional systems.

MQB devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.

Leading manufacturers include Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.

421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
25–48 of 421
Cleared Feb 03, 2023
Digital Flat Panel Detector
K230059
Ray Imaging Technology (Haining) Limited
Radiology · 25d
Cleared Jan 27, 2023
14HQ721G-B
K223546
Lg Electronics.Inc
Radiology · 63d
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687
Careray Digital Medical Technology Co., Ltd.
Radiology · 21d
Cleared Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009
Allengers Medical Systems Limited
Radiology · 59d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124
DRTECH Corporation
Radiology · 46d
Cleared Nov 17, 2022
SKR 3000
K223267
Konica Minolta, Inc.
Radiology · 24d
Cleared Oct 20, 2022
Mercu 1717V
K222886
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Oct 17, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K222855
Canon, Inc.
Radiology · 26d
Cleared Sep 29, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K222687
Canon, Inc.
Radiology · 23d
Cleared Sep 27, 2022
Digital Radiography CXDI-CS01
K222661
Canon, Inc.
Radiology · 25d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239
Vieworks Co., Ltd.
Radiology · 228d
Cleared Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
K221549
Careray Digital Medical Technology Co., Ltd.
Radiology · 62d
Cleared Jul 22, 2022
14HQ701G-B
K221394
Lg Electronics.Inc
Radiology · 70d
Cleared Jul 22, 2022
10HQ701G-B
K221461
Lg Electronics.Inc
Radiology · 64d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512
Vieworks Co., Ltd.
Radiology · 57d
Cleared Jul 15, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K221876
Canon, Inc.
Radiology · 17d
Cleared Jul 13, 2022
17HQ701G-B
K221434
Lg Electronics.Inc
Radiology · 57d
Cleared Jun 29, 2022
Flat Panel Detector
K221714
Iray Technology Taicang , Ltd.
Radiology · 16d
Cleared Jun 16, 2022
Wireless Digital Flat Panel Detector
K221345
Iray Technology Taicang , Ltd.
Radiology · 38d
Cleared Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K221620
Canon, Inc.
Radiology · 11d
Cleared May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K221144
Radisen Co., Ltd.
Radiology · 23d
Cleared May 05, 2022
17HQ901G-B
K220559
Lg Electronics.Inc
Radiology · 66d
Cleared Apr 28, 2022
Digital flat panel detector
K220536
Iray Technology Taicang , Ltd.
Radiology · 63d
Cleared Apr 14, 2022
Yushan X-Ray Flat Panel Detector with DROC
K220510
Innocare Optoelectronics Corp.
Radiology · 51d